A biowaiver means that in vivo bioavailability and/or bioequivalence studies may be waived (not considered necessary for approval). As a result, they represent a useful and cost-effective alternative to performing in vivo studies for generic drugs, however they can be challenging to get right first time.
This course will improve your understanding of various biowaiver types to ensure success in your future applications. Study 8 modules over 4 weeks, using case studies and practical guidance. By examining the requirements for BCS-based, Strength and IVIVC biowaivers, you will have the confidence and skills to implement a strategic approach for new product registrations.
Jean-Michel Cardot is a professor and Head of the Department of Biopharmaceutics and Pharmaceutical Technology at the Universite d’Auvergne, France. His laboratory research fields are dissolution, bioequivalence and IVIVC. His personal research fields are biopharmaceutical development of drugs, in vivo bioequivalence and IVIVC.
This course is designed for professionals involved in the development/ registration of generic products. Attendees may work in the following areas:
What is an Online Academy course?
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.
Over 4 weeks students will learn through:
Once you have registered you will be given login details to access the course.
The trainer was very experienced with many examples and encouraged time for questions.
The trainer was very knowledgeable and had good presentation skills.
The knowledge of the trainer was excellent. There were a lot of practical examples given including issues which I had encountered in the past.